BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS HCG 60 TESTS

    MDR report key: 11058408 · Received December 22, 2020

    Report

    Report Number
    8020790-2020-00141
    Event Type
    Malfunction
    Date Received
    December 22, 2020
    Report Date
    March 16, 2021
    Manufacturer
    BIOMERIEUX SA
    Product Code
    DHA
    PMA / PMN Number
    K141133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN CANADA REGARDING AN OUT OF RANGE LOW RESULT IN ASSOCIATION WITH THE VIDAS® HCG 60 TESTS (REF 30405, LOT 1007956460) WHEN TESTING AN EXTERNAL QUALITY CONTROL SAMPLE USING THEIR MINIVIDAS® BLUE INSTRUMENT (REF. (B)(4), SERIAL NUMBER(B)(6). THE CUSTOMER¿S SAMPLE WAS REQUESTED FOR THE INVESTIGATION; HOWEVER, THE SAMPLE WAS NO LONGER AVAILABLE. NO ANOMALIES WERE IDENTIFIED DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES FOR VIDAS® HCG LOT 1007956460 / 210304-0. THE COMPLAINTS LABORATORY ANALYZED THE CONTROL CHARTS OF 5 INTERNAL SAMPLES CLOSE TO THE EXTERNAL QUALITY CONTROL SAMPLE ON 7 DIFFERENT BATCHES OF VIDAS® HCG REF 30405, INCLUDING THE CUSTOMER¿S LOT 1007956460 / 210304-0. THE ANALYSIS SHOWED THAT ALL RESULTS WERE WITHIN SPECIFICATIONS. THE CUSTOMER'S LOT WAS IN THE TREND OF THE OTHER VIDAS® HCG REF 30405 LOTS. AS THE CUSTOMER'S SAMPLE WAS NOT AVAILABLE AT THE INVESTIGATION TIME, THE COMPLAINTS LABORATORY TESTED THREE (3) EXTERNAL QUALITY SAMPLES FROM THE FRENCH EXTERNAL QUALITY CONTROL ASSESSMENT PROBIOQUAL ON VIDAS® HCG LOT 1007956460 / 210304-0 RETAIN KIT. ALL SAMPLES RESULTS WERE WITHIN THEIR EXPECTED PROBIOQUAL SPECIFICATIONS. BIOMERIEUX DID NOT REPRODUCE THE ISSUE REPORTED BY THE CUSTOMER, NAMELY A NON-REPRODUCIBLE AND TOO LOW RESULT, WHEN TESTING EXTERNAL SAMPLES ON VIDAS® HCG LOT 1007956460 / 210304-0. UNFORTUNATELY WITHOUT A SAMPLE RETURN, FURTHER INVESTIGATION CANNOT BE PERFORMED ON THIS ISSUE. ACCORDING TO INVESTIGATION, THERE IS NO RECONSIDERATION OF THE PERFORMANCE OF VIDAS® HCG REF 30405 LOT 1007956460 / 210304-0.

    Description of Event or Problem · 1

    NOTE: REFERENCE 30405 IS NOT REGISTERED IN THE UNITED STATES. THE U.S. SIMILAR DEVICE IS PRODUCT REFERENCE 30405-01. A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING AN OUT OF RANGE LOW RESULT IN ASSOCIATION WITH THE VIDAS® HCG 60 TESTS (REF 30405, LOT 1007956460) WHEN TESTING AN EXTERNAL QUALITY CONTROL SAMPLE USING THEIR MINIVIDAS® BLUE INSTRUMENT (REF. 99737, SERIAL NUMBER (B)(4)). THE CUSTOMER STATED THE EXPECTED RANGE OF THE QUALITY CONTROL SAMPLE WAS 572 - 864 U/L, TESTING WITH LOT 1007956460 OBTAINED AN UNDERESTIMATED RESULT OF 558.01 U/L. CUSTOMER SERVICE CONFIRMED THE CUSTOMER¿S MINIVIDAS® BLUE INSTRUMENT QCV TEST OBTAINED PASSING RESULTS. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMERIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1521971 VIDAS HCG 60 TESTS VIDAS® HCG 60 TESTS DHA BIOMERIEUX SA 1007956460

    Patients

    Seq Age Sex Outcome Treatment
    1